In the debate over whether Big Pharma’s perks lead doctors to prescribe high priced brand-name drugs over equally effective generics, the question to ask is whether an industry would direct 90% of a $20 billion marketing budget at doctors if it did not work.

As lawmakers enact measures to limit the drug company’s influence over the medical profession, the profiteers within the industry are beginning to fight to reverse the policies in court. The New Hampshire, “Prescription Confidential Act,” was passed to stop the disclosure of information on doctors prescribing habits to drug companies. The law is now being challenged in court by two data mining firms that profit from selling the information.

IMS Health and Verispan LLC, say the Act violates the First Amendment right to free speech. A trial is scheduled in January 2007, to determine whether the law will stand. Judge Paul Barbadoro, of the US District Court for New Hampshire, refused a request to issue an injunction to temporarily overturn the law until the trial.

The outcome of the case may have an impact in other areas of the country. Congress and several other states are considering similar laws, and the ruling in the New Hampshire is expected to influence their decisions of whether to go forward on the matter.

The Act bars the sale of prescription information on both patients and doctors for commercial purposes. New Hampshire State Representative, Cindy Rosenwald, a sponsor the bill, said the Act is designed to reduce health care costs and protect the privacy of doctors.

She told the Concord Monitor on November 20, 2006, that selling the prescribing information drives up the cost of health care by making it easier for drug companies to push expensive drugs on prescribing doctors.

Medicaid for example, she said, together with the higher cost of drugs for prisoners and state employees adds up to a lot of taxpayer money.

Data on the prescribing habits of doctors has long been used by drug company sales representatives to target their customers. Former sales rep, Kathleen Slattery-Moschkau, told the San Francisco Chronicle, on August 6, 2006, that she received reports on every physician within her sales territory broken down by drug class, as well as “numerous other reports, such as the ‘Heavy Hitter List,'” she said, which would include the top doctors her company was trying to “convert.”

Ms Slattery-Moschkau says the reports helped her determine which doctors “were worthy of spending my monthly budgets on for lunches, dinners, days at the spa, etc.”

Overall, she said, the reports “were a great tool for determining which marketing tactics worked best.”

Drug companies pay enormous amounts of money each year to obtain these records that enable them to provide the reports to their sales reps. According to the Chronicle, IMS Health, one of the main data mining companies, generated revenues in 2005, of $847 million from its “Sales Force Effectiveness Offerings.”

Experts say the use of these profiles increases other health care costs. Dr Sharon Levine, an executive director with the HMO, Kaiser Permanente, told the Chronicle that the high cost of obtaining the records is not only reflected in higher drug prices, but the data itself is used to persuade doctors to prescribe expensive brand-name drugs when cheaper generics would work, causing a rise in patient co-payments and insurance premiums.

According to health care analysts, providing doctors with free drug samples also drives up the prices on prescription drugs in the long run. Studies have shown that supplying doctors with free samples of costly brand-name drugs greatly increases the rate of prescribing of those same drugs and the cost of the samples has to be factored in with increased drug prices. In 2005 alone, doctors were given free drug samples valued at about $16 billion, according to IMS Health.

And then there is the matter of the free meals provided to influence the doctor’s prescribing habits for specific drugs, and not only for doctors – in some instances for their entire staff.

After examining the interaction between doctor’s offices and sales reps, Dr John Scott, an assistant professor at the University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School, told the New York Times, “We found that some offices get breakfast and lunch every day.”

According to the July 28, 2006 Times article, “The cost of the lunches is ultimately factored in to drug company marketing expenses working its way into the price of prescription drugs.”

She said sales reps could gauge the success of a free lunch immediately because they had the numbers from the prescribing records to show what drugs the doctor was prescribing. “If I brought in lunch one week,” she stated, “I could see the following week if that lunch had an impact.”

Analysts say the various methods of courting doctors adds up to mega-bucks over a year’s time. In 2003 alone, the industry spent about $5.3 billion on “detailing,” a term used for the face-to-face promotion activities by sales reps directed at doctors, according to IMS Health.

Early this year, a panel of medical experts called for the adoption of new conflict-of-interest regulations, saying the financial influence of Big Pharma was distorting treatment decisions and scientific findings.

In a paper published in the January 25, 2006, Journal of the American Medical Association, the group said that voluntary efforts to limit industry influence had failed, resulting in the overprescribing of some medications and the withholding of negative findings on others.

Cases like Vioxx, SSRIs for children and spinal implants by Medtronic, which all occurred with voluntary guidelines in place, they said, highlight the need for stricter measures.

The panel, made up of officials from medical schools and the Institute on Medicine as a Profession, called on the 400 teaching hospitals in the US to impose strict new rules, including a ban on all gifts and meals along with tighter restrictions on outside income.

The group also said medical schools and affiliated hospitals should refuse free drug samples and create a voucher system or distribution bank for indigent patients instead. “The availability of free samples is a powerful inducement for physicians and patients to rely on medications that are expensive but not more effective,” the JAMA article noted.

On January 25, 2006, Jordan Cohen, president of the Association of American Medical Colleges, and a co-author of the proposal, told the Washington Post, “We’ve become overly dependent on these kinds of blandishments to support our core activities, and that is jeopardizing public trust and scientific integrity.”

The relationships, he said, can prompt doctors to order unnecessary tests, prescribe more expensive drugs or advocate adding certain medications to a hospital’s list of preferred drugs.

“Drug companies spend $13,000 per physician annually,” said another co-author, Dr David Rothman, a professor of social medicine at Columbia University Medical Center.

“Those marketing tactics,” he told the Post, “are very, very effective at getting physicians to do what each drug company wants — to prescribe their product.”

Other supporters of the proposal include Dr Jerome Kassirer, former editor-in-chief of the New England Journal of Medicine, and Dr David Blumenthal, director of the Institute for Health Policy at Massachusetts General Hospital.

The call for reform is apparently taking hold. On September 12, 2006, the New York Times reported that as of October 1, 2006, “Stanford University Medical Center will prohibit its physicians from accepting even small gifts like pens and mugs from pharmaceutical sales representatives under a new policy intended to limit industry influence on patient care and doctor education.”

The new policy is part of a small but growing movement among academic medical centers, the Times said, noting that the University of Pennsylvania and Yale have also announced similar rules.

In light of the FDA’s recent failure to protect consumers against the dangers of new drugs like Vioxx and the SSRIs, many medical experts now recommend that patients avoid taking a new drug if there is an alternative, saying preapproval studies do not allow for enough time, or include enough patients, to show all the potential side effects.

In her book, “The Truth about Drug Companies: How They Deceive Us and What to Do About It,” Dr Marcia Angell, former editor of the New England Journal of Medicine, tells patients to ask the following questions before accepting a prescription for a new brand-name drug:

(1) What is the evidence that this drug is better than an alternative drug or treatment approach?

(2) Has it been published in a peer-reviewed medical journal, or are you relying on information from drug company representatives?

(3) Is this drug better only because it’s given at a higher dose?

(4) Would a cheaper drug be as effective if it were given at an equivalent dose?

(5) Are the benefits worth the side effects, the expense and the risk of interactions with other drugs I take?

If its a free sample, Dr Angell says to ask the doctor whether there is a generic drug or other less-expensive equivalent to take when the free sample runs out.

Other segments of the health care field are also finding ways to drive down high prescription drugs costs. On November 21, 2006, BlueCross BlueShield of North Carolina announced plans to set up ATM-like machines in doctors’ offices to make it easy for physicians to pass out free samples.

However, the plan has Big Pharma crying foul because these free samples will no longer be the high-priced name-brand drugs, they will be generics.

Like this:

Big Pharma has Americans running to the doctor demanding the latest advertised drug to treat the latest promoted disorder based on the latest commercial they see on TV.

According to a report by CBS News on October 22, 2006, the United States makes up just 5 percent of the world’s population, “but it accounts for a whopping 42 percent of the world’s spending on prescription drugs — more than $250 billion just last year.”

And yet, when compared to nearly two dozen other industrialized countries, the US has the highest infant mortality rate and the lowest life expectancy for people who have reached the age of 60, according to a September 20, 2006 report by The Commonwealth Fund’s Commission on a High Performance Health System.

In August 1997, the FDA relaxed the restrictions on television and radio DTC advertising, permitting drug companies to mention both the name of the drug, and the disease or symptoms that the medication treats in the same ad.

Industry critics say the end result of the easing of restrictions has been massive advertising campaigns that regularly promote drugs for off-label unapproved uses, understate risks and overstate benefits, and make efficacy and safety claims that are not backed up by clinical studies.

The most common strategy used these days to mass-market a drug is “disease mongering” to increase the number of potential customers diagnosed with a new disorder. Big Pharma even hires PR firms to come up with the most sellable names for the disorders.

The key, the company’s president, Jim Dettore, told CBS, is a name that describes the symptom in a nice way, making it OK to seek help, preferably with the client’s drug. “These acronyms allow them to communicate more effectively with less pressure,” Mr Dettore said.

Disease mongering through DTC advertising can dramatically increase the sales of just about any product. For instance, Lamisil is used to treat toenail fungus. The main adverse effect of the fungus is that it turns the toenail yellow and it can hurt, but no one has died of toenail fungus.

However, people taking Lamisil have died from the drug, according to “Pill Pushers,” in Forbes.com on May 8, 2006, “Federal regulators have linked the drug to 16 cases of liver failure, including 11 deaths.”

The Forbes article reports that 10 million Americans have taken Lamisil, at a cost of $850 for a 3-month treatment, even though the drug only cures the problem in 38% of the patients.

The advertising campaign for the drug featured a cartoon character called “Digger the Dermatophyte” being crushed by a giant Lamisil pill.

The ad so overstated the benefits of the drug, Forbes said, that regulators objected and the company was forced to pull the ad. But the campaign was obviously a huge success because in 2004, Lamisil sales increased by 19% to reach $1.2 billion worldwide and held steady in 2005.

Prescription drug advertising has provided a steady stream of revenue for print and broadcast media since the FDA lifted the restrictions. IMS Health, an industry tracking firm, reports that overall in 2004, drug companies spent about $4 billion on DTC advertising.

According to contributing editor, Judy Lieberman, in the July-August 2005, Columbia Journalism Review, the CJR monitored the evening newscasts on ABC, CBS, and NBC for one week in April 2005, and found that network viewers saw an average of 16 ads for prescription drugs and on average 18 commercials for over-the-counter drugs every night.

In 1999, the five networks, including Fox News and CNN, received $569 million in advertising revenue from drug companies, according to TNS Media Intelligence. But by 2004, advertising revenue nearly tripled to $1.5 billion, according to Ms Lieberman.

As far as advertising dollars spent on print media, at the end of 2004, Ms Lieberman found that drug company ads for Time magazine totaled $67 million; $43 million for Newsweek; and the New York Times took in $13 million.

Advertising dollars pay big dividends. A 2003 Harvard Public Health study commissioned by the Kaiser Family Foundation determined that for every $1 spent on direct advertising, drug companies took in an additional $4.20 in sales.

No other drugs in history have received more promotion and media attention than the Cox 2 inhibitors which include Merck’s Vioxx, and Celebrex and Bextra, by GD Searle, a company bought later by Pharmacia. Celebrex went on the market in January 1999, and Vioxx was FDA approved on May 20, 1999.

The study, “Promotion of Prescription Drugs to Consumers: A Look at the Numbers,” in the February 14, 2002, New England Journal of Medicine, found Vioxx to be the most highly promoted drug in 2000 with Merck spending $161 million.

The only real selling point for the Cox 2 inhibitors was the claim by drug makers that the new medications supposedly did not cause stomach bleeding and ulcers that sometimes resulted after lengthily use of painkillers like aspirin, ibuprofen, and other non-steroidal anti-inflammatory drugs (NSAIDs).

That assertion was untrue and in fact, the FDA refused to allow the companies to make that claim in advertising or the drug’s guidelines for use, since it was not backed up by any clinical studies. The package insert that did accompany the new pain relievers contained the same warning as the older NSAIDs.

But never known to let a little FDA warning stand in the way of profits, in no time at all the drug makers had the mainstream press and medical literature flooded with ghost-written articles and press releases with the names of “experts” attached, describing the bleeding problems and deaths caused by NSAIDs, followed by the effectiveness and safety of the Cox 2 inhibitors.

For instance, Vioxx was approved on May 20, 1999, two days later on May 22, 1999, the Washington Post ran the headline, “FDA Approves Pain Reliever with Fewer Side Effects,” and article reported that NSAIDs cause “107,000 hospitalizations and the death of 16,500 people every year.”

Never mind that the same year, a survey by the Centers for Disease Control reported that less than 6,000 people died the year before from any and all types of gastrointestinal bleeding disorders combined.

However, apparently Merck found a different group of people to survey because on the December 26, 2000, Jim Lahrer News Hour, Dr Roger Perlmutter, who was listed as overseeing basic research at Merck, said, “Each year something in excess of 8,500 deaths and more than 50,000 hospitalizations result from the chronic use of non-steroidal anti-inflammatory drugs.”

He claimed that NSAIDs produced dangerous and even deadly side effects in about 4% of patients, including bleeding in the stomach or intestine. “The result,” Dr Perlmutter said, “is an increase in ulceration and severe gastrointestinal complications.”

At the time of their arrival on the market, Wall Street analysts referred to the launch of the Cox 2 inhibitors as the most successful marketing coup in the history of the pharmaceutical industry.

Drug company sales reps swarmed into medical clinics with free samples galore and millions of patients began demanded prescriptions for the new miracle arthritis pain relievers and sales took off the minute the drugs hit the shelves.

Pain relief drugs that cost pennies a day were history and millions of patients were conned into forking over three to 6 bucks for pills that were no more effective, and as it turns out, much less safe than aspirins.

Reportedly, over 100 million people were prescribed Vioxx and massive DTC advertising has been singled out as the main factor that led to an unusually high number of patients being prescribed the drug before the lethal side effects were known.

In an August 30, 2005, interview with Manette Loudon, career FDA scientist, Dr David Graham said the Vioxx disaster would not have been half as bad if not for DTC advertising. “I submit,” he said, “that the numbers would have been far lower than what they were.”

Due to heavy marketing of new drugs like Vioxx, Dr Graham says, patients and doctors will often use a drug that is no better than others already on the market, even though the FDA does not require that new drugs be equivalent to, or better than, the drugs that are already there. All they have to prove is that a drug works better than a sugar pill, he says.

Merck finally withdrew Vioxx from the market in September 2004, but not before an “estimated 88,000-140,000 excess cases of serious coronary heart disease probably occurred in the USA over the market life of Vioxx,” according to Dr Graham.

The US national estimate of the case-fatality rate was 44%, he says, which suggests that many of the excess cases attributable to Vioxx use were fatal.

An expert witness in one of the Vioxx trials, the respected biostatistician, Richard Kronmal, from the University of Washington, testified that as early as April 2001, Merck had data that showed a 4-fold increase risk of death in Vioxx patients from a clinical trial that Merck was conducting to determine whether the drug was effective in treating Alzheimer’s and yet the company continued the study until 2003.

“They had evidence that they were potentially killing people and they let that trial go on for another two years,” he said.

According to Merck, as of September 30, 2006, there are close to 24,000 Vioxx-related lawsuits filed against the company on behalf of over 41,000 plaintiff’s groups, and an additional 275 class actions seeking personal injury damages or reimbursement for the costs of buying a drug that Merck misrepresented as being safe and more effective than it actually was.

The Vioxx debacle has placed Merck, the FDA, and the issue of drug safety on center stage and the spotlight is focused on the faulty process by which new drugs are approved and advertised along with the inadequate post approval safety surveillance program.

Lawmakers on both sides of the isle have accused FDA officials of being too cozy with Merck and the over-promotion of Vioxx has led to several pieces of reform legislation aimed at the FDA’s lack of regulatory efforts toward curtailing DTC advertising abuses.

On November 17, 2006, the Senate Committee on Health, Education, Labor, and Pensions, held a hearing and gave Democrats their first chance to exercise their muscle to demonstrate how they will deal with the FDA’s stance on DTC once they become the majority in Congress next year.

The hearing titled, “Building a 21st Century FDA: Proposals to Improve Drug Safety and Innovation,” focused on Senate Bill 3807, the “Enhancing Drug Safe and Innovation Act of 2006,” co-sponsored by committee chairman, Senator Michael Enzi (R-WY), and Senator Ted Kennedy (D-MA), the next chairman of the committee.

A prepared statement from Senator Enzi’s office said the Senate Bill will “ensure that drug safety is not an afterthought,” and Senator Kennedy said that as chairman, he plans to hold a series of hearings aimed at FDA oversight early in 2007.

Dr Steven Nissen, MD, from the Cleveland Clinic, testified at the hearing and told the panel that the post marketing surveillance system for prescription drugs functions poorly. “Adverse event reporting,” he notes, “is voluntary and studies show that only 1 to 10% of serious adverse events are ever reported to the Agency.”

And therefore, he informed the committee, “the actual incidence of serious or life-threatened complications cannot be calculated accurately.”

Dr Nissen also said that DTC advertising requires legislative action. “The standard for acceptable DTC advertising,” he told the panel, “should require demonstration of a compelling public health benefit for this type of communication.”

“Drugs with an addiction potential, such as sleeping medication,” he said, “should be specifically prohibited from consumer advertising.”

As it is now, according to Pill Pushers, by Forbes on May 8, 2006, prescriptions for sleeping pills increased 48% in five years to 43 million prescriptions annually, driven by the DTC advertising of Ambien and Lunesta, and sales in the same period rose to $2.76 billion.

Jim Guest, president and CEO of Consumers Union, publisher of Consumer Reports, testified on behalf of Consumers Union, and asked lawmakers to limit advertising of new drugs for three years, instead of the two year requirement in the Senate bill, because most adverse events do not show up until nearly seven years after a drug has been on the market, he said.

“Appropriate DTC advertising plays a valuable role in educating patients about diseases and treatments,” Mr Thomas told the panel.

“The value of this education to patients,” he continued, “as well as important First Amendment issues that arise from banning truthful speech, even for a period of time, must be carefully considered before legislating in this area.”

Mr Guest testified that consumer advertising is not an educational tool, but rather a vehicle to mass market drugs before the serious side effects become known. “The direct-to-consumer advertising,” he told the panel, “is not a good way for consumers, physicians or medical providers to be informed.”

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